Just when Beth Hubbard should have been feeling great, her healthfell apart.
A 34-year-old housewares designer in the St. Louis area, Hubbard hadrecently gotten married.
She liked the creativity of her career.
She criedand called in sick for days at a time.
“I chalked it up to exhaustionafter the whirlwind of the wedding and honeymoon,” Hubbard says.
Yet she wasn’t getting better.
And she continued on theBudeprion XL the entire time.
Her friend said she’d recently gone off Wellbutrin and hadsome leftover pills Hubbard could use.
Within a week, Hubbard’s troubling symptoms vanished.
Her energycame roaring back.
She called her doctor to complain about the generic and request anew prescription for the brand name only.
The nurse’s response flooredher.
“Yes,” the nurse said matter-of-factly.
“We hear that all thetime.”
Many lawmakers and health-policy experts say the trend has littledownside.
“That’s not happening, and the risk to consumersis potentially huge.
Theagency vowed to inspect each factory before giving the green light toany program.
But SELF found that the FDA’s reforms have largely fallen by thewayside.
Manufacturing problems have come tolight, with six generic companies recalling 20 products in 2008.
KVPharmaceutical Company, a maker of heart and pain medicine, recalledeverything it made.
“My question is, Are we satisfied?”
“Generic companies are popular on CapitolHill because the industry is powerful and voters are anxious for cheaperdrugs.
But as Beth Hubbard discovered, patients are finding starkdifferences among drugs the FDA has deemed equivalent.
Consumers describeddrugs that had no effect, caused bizarre side effects or made conditionsworse.
Joe Graedon says he has been “astounded” by the outpouring.
“I’mnot in the back pocket of the pharmaceutical companiesI wantgenerics to be good,” he says.
“But the more we dug, the more werealized nobody is monitoring the equivalence of these drugs.”
If the drugs were truly bioequivalent, what could account for suchdivergent reactions?
Graedon compares the effect toguzzling alcohol.
“But if youdrink the whole thing in 15 minutes, you’re getting too much too fast.”
That means generic companiesmust sometimes engineer their own release mechanism, as happened in thecase of Budeprion XL.
One afternoon, aseizure came on suddenly.
Dr. French describes the caseas a “clear-cut failure” of the genericand not the only one shehas seen.
“Butthere are patients holding off seizures by the skin of their teeth.”
Dr. Antalis cites the dozens of versionsof warfarin, the generic for the blood thinner Coumadin.
Physicians' groups, including the American Academy of Neurology inSt.
They’ve also called on the FDA tostudy the issue in more detail.
“People hear the wordgeneric, and they think about generic cornflakes or plastic wrap,” Dr.Kesselheim says.
Others dispute that notion.
He estimates thatat least 75 of his patients have complained about the 300 mg genericversion of Wellbutrin XL.
She knew onlythat they were helping her get healthy after years of battlingschizoaffective disorder.
Over the next six months, shefell into a deep depression.
“Iwasn’t eating; I couldn’t get my schoolwork done.
I was crying all thetime.”
Out of the blue, Stephanie’s pharmacy switched her back to themedicine made by Pliva.
“Within days, I was a brand-new person.
Iremember lying in bed thinking, What did I do differently?”
“When people are mentally ill, changing their drugs is like playing withsomeone’s mind.
I could have committed suicide and no one would haveknown why.”
What she could not know was that the government shared her dim viewof Ranbaxy’s medicine.
In August 2005, a Ranbaxy insider had passed whistle-blowinginformation to public-health experts in the United States.
Officialsworried that Ranbaxy had sold dubious AIDS drugs to the taxpayer-fundedprogram.
And in the months that followed, evidence would surface thatsuspect Ranbaxy treatments were reaching Americans, too.
Ranbaxy admitted the errors and told the FDA theywould put procedures in place to prevent them from happening again.
Brand-name drugs are made overseas, too,but globalization has been most dramatic in the generic industry.
Inspections commonly find unsterile work areas or substandardmanufacturing practices, former FDA officials say.
In many cases, companies can give themselves a cleanbill of health.
“The FDA does an inspection and rarely goes back,” Dr.Liang says.
“Anything can happen beyond that point.
It’s a hugeregulatory gap.”
Those checks appear to have failed.
Like a quart of milk in the fridge, drugscan only go bad.
The agency had the documentsand was amassing more evidencethat the company’s products might be dangerous.
In 2007, federal investigators raided Ranbaxy facilities inNew Jersey, seizing documents and computers.
“Ranbaxy remainscommitted to providing high quality medicines at affordable prices toU.S.
patients,” he adds.
So how can authorities ensure genericdrugs are safe for patients?
This is beginning to happen.
Rep.Dingell’s bill, the FDA Globalization Act of 2009, would provide fundsfor further reforms.
Let’s say wetest 10 tablets and they’re making 100,000?
That’swhat Beth Hubbard has done.
She doesn’t blame him for what happened.
You have to know your own body and beyour own advocate.”
Photo Credit: Devon Jarvis
